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| Name | Class |
|---|---|
| National Malaria Control Program | OTHER |
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In Tanzania, according to the National Malaria Control Programme (NMCP), malaria prevalence has declined from an average of 18.1% in 2008 to 7% in 2017, marked as an epidemiological transition from meso-endemic to hypo-endemic levels with variation across and within regions and/or councils. Children of school-age have become increasingly more vulnerable as compared to those aged less than five years. In high-transmission settings, up to 70% of school-aged children harbour malaria parasites which is mostly asymptomatic, accounting for around 50% of the mortality, 13-50% of all school absenteeism. The NMCP developed a supplementary malaria midterm strategic plan (SMMSP 2018-2020) to customise malaria interventions by stratifying the burden of malaria in Tanzania mainland and recommended use of Dihydroartemisinin-Piperaquine (DP) for intermittent preventive treatment in school children (IPTsc) in high malaria strata. The investigators plan to evaluate the implementation of IPTsc using DP, given three times a year, for evidence on the operational feasibility and effectiveness of IPTsc on clinical malaria incidence at a high endemic area in Handeni District Council (DC), Handeni Town Council (TC) and Kilindi DC of Tanga region, Tanzania.
The study is an effectiveness-implementation hybrid trial to assess feasibility and effectiveness of IPTsc using DP against standard of care (control). Wards in the three study districts (Handeni DC, Handeni TC and Kilindi DC) will be the randomisation unit (clusters). Each ward will be randomised to implement IPTsc or not (control). In all wards in the IPTsc arm, the interventional drugs (DP) will be given at an interval of four months, three times a year. For study evaluation of the impact of intervention, in each district representative randomly selected wards, will provide randomly selected school per ward (24 in total) to formulate part of evaluable children per intervention. Mixed design methods will be used to assess the feasibility and acceptability of implementing IPTsc as part of a more comprehensive school children health package.
The study is expected to be operationally feasible given existing school health programme for Neglected Tropical Disease (NTD) control and the school net programme (SNP). IPTsc is expected to increase malaria case management effectiveness and to have additional effect in reducing the burden of disease on top of optimal access to malaria case management (MCM) and malaria vector control (MVC) initiatives e.g. early diagnosis and treatment, and insecticide-treated nets (ITNs) coverage, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPTsc arm | Experimental | Dihydroartemisinin-Piperaquine (DP) for intermittent preventive treatment in school children (IPTsc) will be given in all wards in the IPTsc arm at an interval of four months, three times a year. |
|
| Control | No Intervention | No intervention will be given to wards randomised in this arm |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dihydroartemisinin-Piperaquine (DP) | Drug | Dihydroartemisinin-Piperaquine (DP) for intermittent preventive treatment of malaria in school children (IPTsc). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficiency of school health teachers to deliver antimalarial drugs to school children in high endemic regions | Efficiency in terms of percentage of children given a complete dose in each round. | 1 year from start of intervention |
| Clinical malaria incidence | Malaria incidence will be collected in terms of number of episodes a child gets malaria. | from month 0 till month 12 of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in malaria incidence per 1000 population at local health facility level | Number of malaria episodes before and after intervention in a respective ward | from month 0 till month 12 of follow up |
| Change from baseline in haemoglobin concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of school children with malnutrition | Weight and height will be combined to report BMI in kg/m^2, WHO's BMI z-score will be used to categorise nutrition status. | at month 0 (baseline) and at month 12. |
The following eligibility criteria are used to enroll participants on for close monitoring follow ups assessing the effectiveness part of the study protocol.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P.A Lusingu, MD, PhD | National Institute for Medical Research, Tanga, Tanzania | Study Director |
| Ally Mohamed, MD | National Malaria Control Programme, Tanzania | Study Director |
| Geofrey Makenga, MD, Msc, PhD fellow | National Institute for Medical Research, Tanzania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Handeni Town Council, Handeni and Kilindi Districts | Tanga | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41278241 | Derived | Makenga G, Mmbando B, Seth MD, Baraka V, Challe DP, Francis F, Mhina AD, Liheluka E, Minja DTR, Chiduo M, Mtove G, Mandara C, Gesase S, Segeja MD, Kamugisha M, Hayuma PM, Mbwana JR, Sebukoto H, Malabeja A, Tupa JB, Ngede SJ, Lusasi A, Chacky F, David A, Thawer SG, Mohamed A, Aaron S, Lazaro S, Molteni F, Nkayamba A, Bastiaens H, Van Geertruyden JP, Lusingu JPA. Implementation and effectiveness of intermittent preventive treatment in school aged children using dihydroartemisinin-piperaquine to reduce malaria burden: an implementation research of a cluster randomised trial in Tanzania. EClinicalMedicine. 2025 Nov 7;90:103628. doi: 10.1016/j.eclinm.2025.103628. eCollection 2025 Dec. | |
| 36609279 |
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The study is an effectiveness-implementation hybrid trial to assess feasibility and effectiveness of IPTsc using DP against standard of care (control). Wards in the three study districts (Handeni DC, Handeni TC and Kilindi DC) will be the randomisation unit (clusters). Each ward will be randomised to implement IPTsc or not (control).
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individual change in Haemoglobin before and after intervention
| measured at month 12 |
| Number of participants with treatment-related adverse events | Number of participants with treatment-related adverse events encountered by subjects per study arm | through study completion, an average of 1 year" |
| Cardio safety profile by QTc prolongation from baseline | measured by ECG | Day 1, 2,3 and 7 after before and after dosing |
| Acceptability of IPTsc in communities with high malaria endemicities | Through in depth interview in a guided questionnaire | At month 8 of implementation |
| Derived |
| Makenga G, Seth MD, Baraka V, Mmbando BP, Challe DP, Francis F, Mhina A, Minja DTR, Chiduo M, Mandara C, Liheluka E, Gesase S, Segeja M, Mtove G, Kamugisha M, Lusasi A, Chacky F, David A, Thawer S, Mohamed A, Lazaro S, Molteni F, Nkayamba A, Van Geertruyden JP, Lusingu JPA. Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania: methodology, challenges, and mitigation. Malar J. 2023 Jan 6;22(1):7. doi: 10.1186/s12936-022-04428-8. |
| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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